necrotizing enterocolitis
Conditions
Interventions
Anastomosis or stoma formation after bowel resection
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. Suspected NEC 2. Need for laparotomy based on: 2.1. Radiological signs of intestinal perforation or 2.2. Failure of improvement with medical treatment 3. Aged 0 - 6 months, either sex
Exclusion criteria
Exclusion criteria: 1. No evidence of NEC (e.g. intestinal volvulus) 2. Focal intestinal perforation (since many surgeons would not perform a stoma) 3. Extensive NEC precluding intestinal anastomosis (intestinal resection will result in short bowel) 4. NEC affecting the colon that cannot be completely assessed because of risk of bleeding 5. Patient's instability during the operation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point of the study will be duration of parenteral nutrition (days), as this reflects the recovery of intestinal function after NEC and will be affected by complications and/or need for further procedures. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary end points of the study will be: 1. mortality at 1, 3 and 6 months after randomization. 2. number and type of surgical procedures performed (including insertion of central venous lines); 3. hospital stay (days) for survivors and non survivors; 4. intestinal absorptive function. This will be assessed by measuring: i) calorie intake (kcal/kg/day) both enterally and parenterally 1 month and 6 months after randomization; ii) weight gain at 1 month and 6 months after randomization; iii) time (days) to full enteral feeding; iv) requirement for medication to slow intestinal transit time. 5. intestinal complications: a) stricture (of either anastomosis or remaining intestine, confirmed by a contrast study and/or histology); b) anastomotic leak; c) prolapse of stoma; d) stoma necrosis; e) intestinal obstruction; f) high output stoma; g) recurrence of NEC; 6. wound complication (infection, incisional hernia, dehiscence); 7. days on antibiotics, incidence of sepsis (positive blood culture), intraabdominal abscess requiring drainage or reoperation; 8. intraventricular haemorrhage (ultrasound scan of the brain at enrolment in the trial and 2 weeks after randomization); intraventricular haemorrhages will be graded (grade I to IV) according to their extent and severity. 9. respiratory function. This will be assessed by recording the need for assisted ventilation or oxygen dependency at 1 and 6 months after randomization. 10. cost of hospital treatment 11. time to death (days); 12. cause of death (related to abdominal sepsis/not related to abdomen [cardiac anomaly/cerebral haemorrhage/other]). | — |
Countries
Netherlands
Outcome results
None listed